Significance and Use
4.1 A variety of irradiation processes use low energy electron beam facilities to modify product characteristics. Dosimetry requirements, the number and frequency of measurements, and record keeping requirements will vary depending on the type and end use of the products being processed. Dosimetry is often used in conjunction with physical, chemical, or biological testing of the product, to help verify specific treatment parameters.
Note 2: In many cases dosimetry results can be related to other quantitative product properties; for example, gel fraction, melt flow, elastic modulus, molecular weight distribution, or degree of cure.
4.2 Radiation processing specifications usually include a minimum or maximum absorbed dose limit, or both. For a given application these limits may be set by government regulation or by limits inherent to the product itself.
4.3 Critical operating parameters must be controlled to obtain reproducible dose distribution in processed materials. The electron beam energy, beam current, beam width and process line speed (conveying speed) affect absorbed dose.
4.4 Before any electron beam facility can be routinely utilized, it must be characterized to determine the relationship between dose to product and the main operating parameters. This involves testing of the process equipment, calibrating the measuring instruments and the dosimetry system, and demonstrating the ability to consistently deliver the required dose within predetermined specifications.
4.5 In order to establish metrological traceability for a dosimetry system and to measure doses with a known level of uncertainty, it is necessary to calibrate the dosimetry system under irradiation conditions that are consistent with those encountered in routine use. For example, a dosimetry system calibration conducted using penetrating gamma radiation or high energy electrons may result in significant dose measurement errors when the dosimetry system is used at low energy electron beam facilities. Details of calibration are discussed in Section .
1.1 This practice covers dosimetric procedures to be followed in installation qualification, operational qualification and performance qualification (IQ, OQ, PQ), and routine processing at electron beam facilities to ensure that the product has been treated with an acceptable range of absorbed doses. Other procedures related to IQ, OQ, PQ, and routine product processing that may influence absorbed dose in the product are also discussed.
1.2 The electron beam energy range covered in this practice is between 80 and 300 keV, generally referred to as low energy.
1.3 Dosimetry is only one component of a total quality assurance program for an irradiation facility. Other measures may be required for specific applications such as medical device sterilization and food preservation.
1.4 Other specific ISO and ASTM standards exist for the irradiation of food and the radiation sterilization of health care products. For the radiation sterilization of health care products, see ISO 11137-1. In those areas covered by ISO 11137-1, that standard takes precedence. For food irradiation, see ISO 14470. Information about effective or regulatory dose limits for food products is not within the scope of this practice (see ASTM and ).
1.5 This document is one of a set of standards that provides recommendations for properly implementing dosimetry in radiation processing, and describes a means of achieving compliance with the requirements of ISO/ASTM . It is intended to be read in conjunction with ISO/ASTM .
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.